SOLICITATION NOTICE
Q -- Notice of Intent to Sole Source
- Notice Date
- 3/2/2007
- Notice Type
- Solicitation Notice
- NAICS
- 424210
— Drugs and Druggists' Sundries Merchant Wholesalers
- Contracting Office
- Department of Health and Human Services, Center for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, GA, 30341-4146, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- 000HCVJE-2007-40328
- Response Due
- 3/17/2007
- Archive Date
- 4/1/2007
- Description
- The Centers for Disease Control and Prevention (CDC) is engaged in a Randomized, Placebo-Controlled Study of Limited vs Continuous Isoniazid Tuberculosis Preventive Therapy for HIV-infected Persons in Botswana. Within 120 days of the contract award, the vendor shall supply for the Division of Tuberculosis Elimination (DTBE) at the CDC, 3 batches of five hundred thousand (500,000) scored tablets of Isoniazid (INH), ?100 mg? per batch for a total of one million and five hundred thousand 1,500,000 scored tablets of Isoniazid, 100 mg packaged in large containers. Additionally, the vendor shall supply 3 batches of five hundred thousand 500,000 scored tablets of placebo, ?100 mg? per batch for a total of 1,500,000 placebo 100 mg tablets. The placebo tablets are to be packaged in large containers, which shall exactly match the above mentioned 100 mg scored tablets of Isoniazid. The tablets are to be identical in look, smell, taste, texture, and have the same consistency as the actual INH tablets that were manufactured by Versapharm in August 2003. The tablets will be delivered to the Health and Human Services (HHS) Supply Service Center by the vendor. In order to eliminate any bias and to ensure research integrity, it was determined to be absolutely critical that the placebo tablets be identical in look, smell, taste, texture, and have the same consistency as the actual INH tablets. These products are to be produced in accordance with good manufacturing practice, and the active drug (Isoniazid) must be approved by the U.S. Food and Drug Administration for the treatment of tuberculosis. The bottles of active drugs should be appropriately labeled and include an expiration date that should not be less than two (2) years from the date of manufacture of the product. In addition, large containers of drugs are to be delivered no later than one week after manufactured and shipping cost (FOB destination) should be included in the estimates for the cost of the manufacturing of the tablets. The CDC and the Government of Botswana are collaborating on a country-wide effort to reduce the impact of the severe HIV epidemic on its population. Botswana is experiencing one of the world?s most severe AIDS crises that looms as a disaster of unprecedented proportions. The global burden of HIV/AIDS in Botswana is the highest in sub-Saharan Africa, where 83% of the world?s AIDS deaths have occurred, and where four-fifths of all HIV-positive women live. Despite a relative stabilization of infection rates in some countries in West Africa, the HIV/AIDS epidemic continues to grow at an alarming rate in Southern Africa. Like many countries in this region, Botswana has been disproportionately affected by the AIDS pandemic. Over 20% of the population are believed to be HIV positive and the Botswana National Aids Coordinating Agency?s 2005 Sentinel Surveillance reports 33.5% HIV infection in participating pregnant women. Botswana estimates that as many as 25 babies a day are born with HIV. AIDS-related conditions are responsible for 10% of annual deaths, with women and adolescents particularly at risk. TB is by far the single leading cause of death among adults with AIDS in Botswana. Based on Sentinel surveys in 2005, an estimated 15% of the total population and 24% of the economically productive age group (15-49 years old) are living with HIV infection. The rate of TB infection in Botswana (633/100,000 in 2003) is one of the highest in the world. Under this collaborative activity, Botswana is the first African country to have launched a nation wide TB prevention program using Isoniazid Preventive Therapy (IPT) for HIV infected individuals. This program was initiated in 2003. Currently, nearly 50,000 HIV infected individuals have received or are receiving IPT. The CDC program in Botswana is a strong supporter of the IPT program and is providing technical assistance, training for health care workers, supplying educational materials, and supporting program monitoring and evaluation. CDC?s collaboration includes support to strengthen the IPT program throughout the country through the provision of technical assistance, counseling space, equipment, and materials for program sites throughout Botswana. As an extension of the technical collaboration with the government of Botswana on IPT and TB prevention for HIV infected individuals, CDC launched a 2000-person clinical trial to evaluate the optimal duration of IPT for the best level of protection against TB. The clinical trial, which was fully enrolled in June 2006 will compare 6 months of treatment (Government-recommended duration) with 3 years of treatment, once completed. The CDC has identifed the VersaPharma Incorporated, 1775 West Oak Parkway, Marietta, Georgia, as the sole source to provide the requirement, in accordance with Federal Acquisition Regulation 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements. However, responsible sources who believe they can provide the required services may submit a written capability statement, via e-mail, no later than 15 days from the published date of this announcement. Telephone inquiries will be considered nonresponsive. If no responses are received the award will be made to VersaPharma Incorporated.
- Place of Performance
- Address: HHS Supply Service Center, Building 14, Perry Point, Maryland,
- Zip Code: 30062
- Country: UNITED STATES
- Zip Code: 30062
- Record
- SN01242521-W 20070304/070302220359 (fbodaily.com)
- Source
-
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